Impactful QP - GMP Compliance & Batch Release Leader

Catalent Pharma Solutions; Bathgate; On-site; GBP 65,000 - 75,000; Full time

Benefits offered by this job

Pension scheme matching up to 7.5%

Life assurance

BUPA private medical insurance

Generous holiday entitlement

Trade leave option

Job summary

Catalent Bathgate, UK is seeking a Qualified Person to oversee GMP compliance and certify products prior to release. The role involves reviewing GMP documentation, supporting deviations and investigations, and ensuring regulatory adherence across EU GMP regulations.

The successful candidate will collaborate with internal teams and clients to resolve quality issues, participate in recalls and continuous improvements, and contribute to a strong Patient First culture at Catalent.

Qualifications

• Qualified Person in accordance with 2001/20/EC and/or 2001/83/EC.
• Clinical trial experience preferred.
• Experience in biotechnology preferred.

Responsibilities

• Certify and release IMP and marketed product batches, ensuring GMP and regulatory requirements are met prior to distribution.
• Review and approve GMP documentation, including batch records, deviations, investigations, and other quality records.
• Ensure ongoing compliance with the Quality Management System and EU GMP regulations.
• Assess, approve, and support deviation, complaint, and quality investigations to ensure timely resolution.
• Collaborate with internal teams to resolve batch release issues and drive compliance improvements.
• Review and release SOPs and other controlled quality documents.
• Act as key quality contact for clients, sites, and Catalent locations on batch release and regulatory matters.
• Participate in product recall activities and quality improvement initiatives.

Skills

GMP regulations

Quality assurance

Regulatory oversight

Education

Bachelor of Science or equivalent

Job description

Catalent Bathgate, UK is seeking a Qualified Person to oversee GMP compliance and certify products prior to release. The role involves reviewing GMP documentation, supporting deviations and investigations, and ensuring regulatory adherence across EU GMP regulations.

The successful candidate will collaborate with internal teams and clients to resolve quality issues, participate in recalls and continuous improvements, and contribute to a strong Patient First culture at Catalent.